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Completed

NCT Number: NCT01607580

Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)

Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT.

It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).

The study hypothesis:

Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute GVHD

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital, Beijing, China

Loading trial locations.

About this study

patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no severe diarrhea no serious infection

Exclusion criteria

  • serious diarrhea active,uncontrolled infection

Treatment and study plan

low-dose glucocorticoid Methylprednisolone

Drug

patients receive low-dose glucocorticoid from day 5 post transplant

Other names: Methylprednisolone

Primary outcomes

  1. incidence of acute graft-versus-host disease

    Time frame: paticipants will be followed for the duration of hospital stay,an expected average of 100 days

    number of participants with acute graft-versus-host disease at 100 days

Secondary outcomes

  1. incidence of infection

    Time frame: participants will be followed for the duration of hospital stay,an expected average of 100 days

    number of participants with infection (including bacterium,EB virus, cytomegalovirus and fungus ) at 100 days

Other outcomes

  1. engrafment

    Time frame: participants will be followed for the duration of hospital stay,an expected average of 100 days

    numbers of participants with the engrafment of neutrophilic granulocyte and platelets at 100 days

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 30, 2012
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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